View clinical trials related to Immunologic Deficiency Syndromes.
Filter by:Smoking is a significant cause of damage to health and quality of life specifically for Veterans with human immunodeficiency virus (HIV). Smoking cessation interventions for this population are lacking. The primary aim of this project is to explore smoking cessation treatment preferences among Veteran smokers living with HIV. The study team will refine the design and content of a smoking cessation treatment for Veteran smokers living with HIV. The intervention uses mobile health and telehealth technology to personalize smoking cessation counseling and medications and provide relapse prevention text messaging.
Tuberculosis (TB) remains the major cause of morbidity and mortality among patients with HIV. Sub-optimal diagnostics contributes towards poor patient outcome and there is an urgent need to identify non-sputum-based point-of-care diagnostic tests. The urine based lateral flow lipoarabinomannan TB diagnostic test (LF-LAM) is a simple, inexpensive point-of-care test. In 2015, the World Health Organization endorsed LF-LAM for conditional use among patients with advanced HIV, but uptake of the test in clinical practices has been poor. The investigators aim to identify point-of-care (POC) strategies that can improve TB case detection and clinical outcomes among patients with advanced HIV. The project includes a main study and two sub-studies. The main study is a multicenter stepped wedge cluster-randomized controlled trial of LF-LAM implementation among patients with advanced HIV with 8-weeks follow-up. LF-LAM will be added to standard care and implemented stepwise at three hospitals in Ghana. Education in national TB treatment guidelines in collaboration with the Tuberculosis Control programme in Ghana, and Clinical audit of clinical staff with feedback, will be used to assess and strengthen LF-LAM implementation. The primary outcome time to TB treatment, for which a sample size of 690 participants will provide >90% power to detect a minimum of 7 days reduction. Secondary outcomes are: TB related morbidity, TB case detection, time to TB diagnosis and overall early mortality at 8 weeks. The HIV-associated TB epidemiology including genotypic analyses of M. tuberculosis isolates obtained through the main study will be described. In sub study A, focused ultrasound of lungs, heart and abdomen will be performed in a sub cohort of 100 participants. In sub study B, the investigators will establish a biobank and data warehouse for storage of blood, urine and sputum samples collected from participants that enter the study at Korle-Bu Teaching hospital. It is expected that LF-LAM will lead to earlier diagnosis and treatment of TB. Findings may further guide scaling-up of LF-LAM. The HIV-associated epidemic including genotypic properties and resistance properties which is important for improved management will be detailed. The investigators further expect to evaluate the potential of bedside ultrasound as a clinical tool in management of HIV/TB co-infected patients. The unique Ghanaian HIV-cohort and biobank may facilitate rapid evaluation of future prognostic biomarkers and new point-of-care TB diagnostic tests.
to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients
The objective is to evaluate if the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. In addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated. If the hypothesis is confirmed, helpful immunological markers will be identified. This will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. Otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.
This observational long-term follow-up study is designed to collect safety and efficacy data from ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA LV encoding for human adenosine deaminase (ADA) gene (EFS-ADA LV), as part of the OTL-101 clinical development program. No investigational medicinal product will be administered to these patients as part of the OTL-101-6 study.
With aging the immune system gets weaker. This makes older adults more susceptible to influenza (flu). Vaccinations help to prevent infection from the flu virus, however the immune system of older adults do not respond as well to vaccines compared to young adults and thus, aren't as well protected from the complications from the flu. This research is being done to determine if Metformin, an FDA-approved diabetes medication, is effective at enhancing immune responses to flu vaccine in older men and women. Participants will be randomly assigned to either metformin or placebo treatment for a total of 22 weeks. Participants will be vaccinated with high-dose flu vaccine after 12 weeks of treatment. Immune responses will be evaluated throughout the study at 6 time points.
Clinical phase 3 study to evaluate the efficacy, tolerability and safety of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases.
Antiretroviral therapy of the mother and of the newborn associated with alternative schemes of breastfeeding can reduce these transmission rates to 1%. The diagnosis of HIV infection in newborns is based on PCR for detection of viral genetic material, a procedure that is expensive and of complex logistics. Tests based on detection of antibodies are faster and cheaper but cannot distinguish infected child or maternal antibodies passed to the fetus through the placenta. Nevertheless, the so-called rapid tests have been implemented in the network of health services because of their simplicity and performance comparable to conventional tests. DPP HIV 1/2 test, produced by Bio-Manguinos/Fiocruz, usage is limited by the manufacturer to over 24 months of age children, though the guidelines control programs already recommend the use from 18 months in Brazil and 9 months in other countries. Data on the accuracy of the rapid test under 24 months of age are scarce. This proposal aims to assess the performance of rapid tests produced by Bio-Manguinhos in diagnostic protocols for HIV infection in children 9-24 months old, in order to obtain empirical data to support the current recommendations on rapid tests, particularly in countries with limited access to tests that require specialized laboratories. The validation of rapid HIV testing in other age groups is a requirement of the national regulatory authorities, and has important implications for programs to control HIV-AIDS in populations from countries with limited access to specialized laboratory resources. The use of the rapid test can also represent a significant reduction in costs, as it allows limiting the use of molecular tests to complex and expensive confirmation cases.
It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA.
This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.